Tuesday, May 25, 2010

New Hepatitis C Drug Achieves 75% Cure Rate

Full Article at: Vertex hep C drug achieves 75 pct cure rate-study

NEW YORK, May 25 (Reuters) - A closely watched experimental hepatitis C treatment being developed by Vertex Pharmaceuticals Inc (VRTX.O) led to a 75 percent cure rate in a pivotal late-stage trial of previously untreated patients, the company said on Tuesday.

The results from the first Phase III study of telaprevir were roughly in line with expectations. Vertex shares, which have slumped recently, rose 14 percent in after-hours trading.

Seventy-five percent of patients who received 12 weeks of telaprevir in combination with current standard treatment of pegylated interferon and ribavirin, followed by either 12 or 36 weeks of standard treatment achieved a sustained virologic response, or SVR, which is tantamount to a cure.

That compared with a 44 percent SVR rate for patients who received the usual 48-week regimen of the standard drugs.

"I think it is a bellwether day for hepatitis C drug development. It's really impressive to see a 75 percent SVR rate in a Phase 3 pivotal trial," said Sanford Bernstein analyst Geoffrey Porges.

He said the result "sets a very high hurdle for competitors." (Reporting by Bill Berkrot; additional reporting by Deena Beasley in Los Angeles; editing by Carol Bishopric)

Tuesday, May 18, 2010

VA Employee Conspires to Defraud, $2 Million

Department of Justice Press Release
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For Immediate Release
May 17, 2010 United States Attorney's Office
Western District of Kentucky
Contact: (502) 582-5911

Two Sentenced in $2 Million Scheme to Defraud Department of Veterans Affairs

LOUISVILLE—Thomas Darrell Bryant, age 39, of LeRoy, West Virginia, and Joe Davis Snooks, Jr., age 62, of Roundhill, Kentucky, were each sentenced to one year and one day in prison, in United States District Court, Louisville, Kentucky, for participating in a scheme to defraud the Department of Veterans Affairs (VA) through the filing of fraudulent military disability claims, United States Attorney David J. Hale of the Western District of Kentucky announced today.

Jennifer B. Coffman, Judge, United States District Court, also sentenced Bryant and Snooks to three years’ supervised release following incarceration. There is no parole in the federal judicial system. In addition, restitution in the amount of $191,853.67 was imposed against Bryant, and restitution in the amount of $141,732 was imposed against Snooks.

Co-defendant Daniel Ryan Parker, who was sentenced to 68 months’ imprisonment in April, was the National Service Office Supervisor for the Disabled American Veterans Service Organization (DAV) in Louisville, Kentucky, and one of Parker’s responsibilities was to assist veterans in their pursuit of military related disability benefits. Co-defendant Jeffrey Allen McGill, who was also sentenced to 68 months’ imprisonment in April, was a Veteran Service Representative with the VA regional office in Louisville, Kentucky, and among other things McGill was responsible for reviewing and rating VA disability claims.

Parker and McGill admitted that between November 2003 and November 2008, they recruited friends, relatives, and acquaintances who were military veterans, including Bryant and Snooks, to file false and fraudulent disability claims with the VA. Parker and McGill either altered the veterans' medical records, or created counterfeit medical records, to give the appearance that the veterans had service related disabilities, resulting in the veterans receiving fraudulent disability benefits for alleged problems such as hearing loss, depression or cancer.

When the VA approves a disability claim, it pays benefits dating back to the original date the claim was received. In addition to falsifying medical records, Parker and McGill also admitted that they fraudulently backdated claims, resulting in large fraudulent lump sum retroactive disability payments, which in several instances were over $60,000. The veterans who participated in the scheme paid kickbacks to Parker and McGill, usually two-thirds of their lump sum payments. In return, the participating veterans kept the monthly tax free disability payments they would have received for the remainder of their lives. The scheme resulted in losses of nearly $2 million before it was discovered.

Co-defendants Dean Anthony Toth and Daniel Joseph Milliner have also pleaded guilty and are scheduled to be sentenced by Judge Coffman in Louisville on July 17, 2010.

The case was prosecuted by Assistant United States Attorneys David R. Weiser and Robert Kilmartin, and it was investigated by the Department of Veterans Affairs, Office of the Inspector General, and the Federal Bureau of Investigation.

Wednesday, May 5, 2010

VAOIG: Philadelphia-VA Unplugged Cancer Monitoring Computer Un-Noticed for a Year

Full Article at: Unplugged VA computer affects treatment of cancer patients

By Bob Brewin 05/04/2010

It took officials at a Veterans Affairs Department hospital in Philadelphia more than a year to learn that a computer used to assess patient's response to treatments for prostate cancer had been unplugged, delaying assessments, according to an inspector general report released on Monday.

The computer ran an application called the VariSeed treatment planning system, which oncologists use to focus radiation treatment on cancer hotspots. But the computer was disconnected from the hospital's network in November 2006 when a vendor and a VA information technology technician unplugged it from a jack that linked it to the main network so they could connect another piece of hardware.

That year, VA clinicians performed 17 procedures to insert radioactive seeds that treat prostate cancer. Without the network connection, X-rays showing the location of radioactive seeds could not be transferred to the VariSeed computer, making it difficult for doctors to determine the patients' response to treatment, the inspector general found. No patient was injured by the error.

The Philadelphia Inquirer reported on Tuesday that 38 veterans or their wives have filed claims against the hospital for alleged injuries. Two have filed federal lawsuits.

The inspector general report comes on the heels of a fine the Nuclear Regulatory Commission levied against the Philadelphia hospital in March. NRC, which oversees the use of nuclear medicine, said the medical center incorrectly placed radioactive seeds in 97 patients who were being treated for prostate cancer between 2002 and 2008. The agency's $227,500 fine was one of its the largest ever, highlighting the significance of the mistreatment of veterans at the hospital.